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P365. Remission status and maintenance therapy outcomes in patients with mild-to-moderate ulcerative colitis (UC): Results from the MOMENTUM study

G. D'Haens1, S. Inglis2, E. Magee3, P. Streck3, D. Solomon3, D. Rubin4, 1Academic Medical Centre, Department of Gastroenterology and Hepatology, Amsterdam, Netherlands, 2Shire, Clinical Development, Basingstoke, United Kingdom, 3Shire, Wayne, PA, United States, 4University of Chicago Medicine, Gastroenterology, Hepatology and Nutrition, Chicago, IL, United States

Background

Once-daily MMX mesalazine provides prolonged release of 5-aminosalicyclic acid for induction and maintenance of UC remission. The relationship between achieving remission and long-term outcomes with maintenance therapy following induction is unclear.

Methods

This completed, phase 3b/4, open-label, prospective study (MOMENTUM study; NCT01124149; sponsor, Shire Development LLC) enrolled pts with mildly-to-moderately active UC (acute flare or newly diagnosed with modified UC Disease Activity Index [UCDAI] total score 4–10, endoscopy score ≥1, and Physician's Global Assessment ≤2) and compared long-term outcomes in pts achieving CR (clinical and endoscopic remission) with pts achieving only PR after induction with MMX mesalazine. Pts received MMX mesalazine 4.8 g/d once-daily (QD) for 8 wks during induction. Pts achieving CR (modified UCDAI ≤1; rectal bleeding and stool frequency scores of 0; ≤1-point reduction in endoscopy score) or PR (modified UCDAI ≤3; combined stool frequency and rectal bleeding score ≤1; not in CR) by Wk 8 could enroll in a 12-month maintenance phase with MMX mesalazine at a reduced dose (2.4 g/d QD). The primary efficacy endpoint was the proportion of pts in CR at Mo 12.

Results

A total of 722 pts enrolled in the induction phase and 717 were treated (mean age 42.9 y; 57.0% male). 472 of 639 pts who completed 8 wks of induction treatment achieved either PR or CR. Subsequently, 469 pts enrolled in the maintenance phase and 461 received treatment (mean age 42.7 y; 56.4% male); 459 had ≥1 post-dose efficacy assessment and 373 completed 12 mos of maintenance. Common reasons for early withdrawal during maintenance included lack of efficacy (n = 40) and adverse events (AEs; n = 24). Of pts in CR and PR, respectively, at Mo 0 of maintenance, 47.8% (87/182) and 26.0% (72/277) were in CR at Mo 12 (P < 0.001). At Mo 12, 76.4% of pts in CR at Mo 0 and 63.5% of pts in PR at Mo 0 had endoscopy scores of ≤1; 62.6% and 42.6% had stool frequency scores of 0; and 65.4% and 57.0% had rectal bleeding scores of 0. Of pts in CR and PR at Mo 0, 37.2% (68/183) and 50.0% (139/278), respectively, experienced ≥1 treatment-emergent AE (TEAE). The most frequent TEAEs were UC (pts in CR at Mo 0, 7.7%; pts in PR at Mo 0, 10.4%); headache (3.3%; 3.6%); influenza (1.6%; 2.9%); and nasopharyngitis (2.7%; 2.2%).

Conclusion

The MOMENTUM study demonstrates that patients with active UC have a higher likelihood of maintaining remission if they attain complete clinical and endoscopic remission after 8 wks of induction treatment. These results suggest that scheduled, successful dose reduction in maintenance phase of UC can occur in pts who have successful induction of CR. The safety profile of MMX mesalazine was consistent with previous clinical studies.